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Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01150656
First received: June 24, 2010
Last updated: February 4, 2011
Last verified: February 2011

June 24, 2010
February 4, 2011
June 2010
July 2010   (final data collection date for primary outcome measure)
  • Obatoclax mesylate activity [ Designated as safety issue: No ]
  • Optimum in vitro combinations of obatoclax mesylate [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) biomarkers of activity [ Designated as safety issue: No ]
  • Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML) [ Designated as safety issue: No ]
  • Disease progression in a xenograft model of MLL-rearranged infant AML [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01150656 on ClinicalTrials.gov Archive Site
  • Physical assessment (in xenograft model) [ Designated as safety issue: No ]
  • Peripheral blast count reduction [ Designated as safety issue: No ]
  • Apoptosis and/or ATG induction [ Designated as safety issue: No ]
  • Modulation of relevant PD biomarkers [ Designated as safety issue: No ]
Same as current
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Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia
SCOR in Targeted Therapies for Infant Leukemias Project 2: Targeting Apoptosis in Leukemia in Infants

RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate on cancer cells. It may also help doctors identify biomarkers related to cancer.

PURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.

OBJECTIVES:

  • Determine comprehensive gene and protein expression profiles of in vitro sensitivity and resistance to obatoclax mesylate in multiple-lineage leukemia (MLL)-rearranged cell lines and primary infant acute myeloid leukemia (AML) samples.
  • Define optimum in vitro combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs in MLL-rearranged leukemia cell lines and primary infant AML samples.
  • Identify synergistic combinations based on a pharmacodynamic modeling and simulation construct.
  • Determine whether combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs improves survival in a xenograft model of MLL-rearranged infant AML.

OUTLINE: This is a multicenter study.

Obatoclax mesylate activity is assessed via the MTT assay. A priori features of acute myeloid leukemia (AML) blasts relating to the apoptosis and ATG cell death pathways and their execution are characterized using microarray analysis and quantitative real-time (Q-RT) PCR. Gene and protein expression is described and quantified using Q-RT PCR and western blot analysis at specific time points after obatoclax mesylate exposure to identify pharmacodynamic biomarkers of activity and characterize the cell death mechanism in multiple-lineage leukemia (MLL)+ AML. The MTT assay is performed using obatoclax mesylate-cytotoxic chemotherapy combinations to determine synergy focusing on common cytotoxic drugs employed in AML treatment regimens.

Obatoclax mesylate efficacy is tested in a therapeutic NOG xenograft model of primary MLL+ infant AML.

Observational
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Leukemia
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: protein expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Genetic: western blotting
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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July 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Cryopreserved samples from infants with AML available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01150656
CDR0000675718, COG-AAML10B17
Not Provided
Gregory H. Reaman, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Carolyn A. Felix, MD Children's Hospital of Philadelphia
National Cancer Institute (NCI)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP